Ignite Creation Date:
2024-05-06 @ 8:16 PM
Last Modification Date:
2024-10-26 @ 3:24 PM
Study NCT ID:
NCT06314256
Status:
RECRUITING
Last Update Posted:
2024-03-18
First Post:
2024-03-11
Brief Title:
Clinical Evaluation of Hyaluronic Acid and Platelet Rich Fibrin Injection Efficacy in Interdental Papilla Reconstruction
Sponsor:
Altinbas University
Organization:
Altinbas University
Study Overview
Official Title:
Clinical Evaluation of Hyaluronic Acid and Platelet Rich Fibrin Injection Efficacy in Interdental Papilla Reconstruction
Status:
RECRUITING
Status Verified Date:
2024-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The goal of this clinical trial is to evaluate and compare the efficacy of injectable platelet rich fibrin i-PRF and hyaluronic acid HA in reconstruction of interdental papilla loss The main questions it aims to answer are
How compareable are above mentioned two interventions i-PRFHA in reconstruction of interdental papilla loss
Which treatment option is better accepted by patients Which treatment option would patients be more satisfied with Participants with multiple interdental papilla loss will be treated with both i-PRF and HA in split-mouth design Researchers will compare two treatment options to see if black triangles caused by interdental papilla loss closes and if yes for how long do they last
How compareable are above mentioned two interventions i-PRFHA in reconstruction of interdental papilla loss
Which treatment option is better accepted by patients Which treatment option would patients be more satisfied with Participants with multiple interdental papilla loss will be treated with both i-PRF and HA in split-mouth design Researchers will compare two treatment options to see if black triangles caused by interdental papilla loss closes and if yes for how long do they last
Detailed Description:
Nowadays individuals give great importance to their appearance and dental aesthetics plays a key role in their personal appearance Dental aesthetics is a combination of white and pink aesthetics formed by teeth and gums The part of the gingival tissue that fills the triangular shaped spaces between the teeth is the interdental papilla The presence of papillae in the teeth is closely related to the distance between the contact point between the teeth and the alveolar bone crest Periodontal diseases traumatic oral hygiene practices incorrect orthodontic forces incompatible restoration contour the presence of diastema as a result of neighbouring teeth not being in contact and tooth loss can cause loss of interdental papillae resulting in the formation of gaps called black triangles In addition to aesthetic problems loss of interdental papillae can cause speech difficulties and food impaction
Interdental papilla loss is one of the most important aesthetic periodontal difficulties and at the same time one of the most difficult problems to treat Various surgical methods and flap designs have been proposed for the treatment and reconstruction of interdental papillae However current surgical methods have limited success and lack predictability especially because the gingival papilla has a sensitive structure and less blood supply compared to other parts of the gingiva Therefore non-surgical methods have gained importance As a result of the development of tissue engineering dermal filling materials have started to be produced in recent years Among these materials hyaluronic acid HA is one of the basic components of connective tissue and especially its water bindingretention property makes it a determinant of tissue volume HA enables the migration of fibroblast cells involved in collagen production and also acts as a liquid matrix where collagen and elastic fibres will proliferate Due to these properties Becker et al first demonstrated in 2010 that it was possible to reconstruct a small area of interdental papilla loss in a minimally invasive and predictable manner using injectable HA gel Subsequently HA injections in interdental papil reconstructions have frequently been successfully reported in the literature
Platelet Rich Fibrin PRF is an autologous membrane form product prepared by centrifugation of the patients own blood This fibrin matrix containing platelets leukocytes and various growth factors is used especially in regenerative periodontal surgical operations Injectable PRF i-PRF obtained by modifying the preparation protocol forms a dynamic hydrogel by increasing the number of cells and releasing growth factors more frequently I-PRF serves as a source of slow-release growth factors that help remodelling of the interdental papilla Using data obtained through standardised photographs and 3D scans the project will evaluate the effectiveness of area and volume closure rates of black triangles caused by papilla loss over a 6-month period and measure patient feedback and satisfaction
Interdental papilla loss is one of the most important aesthetic periodontal difficulties and at the same time one of the most difficult problems to treat Various surgical methods and flap designs have been proposed for the treatment and reconstruction of interdental papillae However current surgical methods have limited success and lack predictability especially because the gingival papilla has a sensitive structure and less blood supply compared to other parts of the gingiva Therefore non-surgical methods have gained importance As a result of the development of tissue engineering dermal filling materials have started to be produced in recent years Among these materials hyaluronic acid HA is one of the basic components of connective tissue and especially its water bindingretention property makes it a determinant of tissue volume HA enables the migration of fibroblast cells involved in collagen production and also acts as a liquid matrix where collagen and elastic fibres will proliferate Due to these properties Becker et al first demonstrated in 2010 that it was possible to reconstruct a small area of interdental papilla loss in a minimally invasive and predictable manner using injectable HA gel Subsequently HA injections in interdental papil reconstructions have frequently been successfully reported in the literature
Platelet Rich Fibrin PRF is an autologous membrane form product prepared by centrifugation of the patients own blood This fibrin matrix containing platelets leukocytes and various growth factors is used especially in regenerative periodontal surgical operations Injectable PRF i-PRF obtained by modifying the preparation protocol forms a dynamic hydrogel by increasing the number of cells and releasing growth factors more frequently I-PRF serves as a source of slow-release growth factors that help remodelling of the interdental papilla Using data obtained through standardised photographs and 3D scans the project will evaluate the effectiveness of area and volume closure rates of black triangles caused by papilla loss over a 6-month period and measure patient feedback and satisfaction
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None